Quality of Life in Pancreas Transplantation

• Conditions: Diabetes Mellitus; Quality of Life
• Interventions: Procedure: Solid Organ Pancreas Transplantation with or without Kidney Transplantation

• Registration Number: NCT03921593
• Lead Sponsor: University of Oxford

Brief Summary

Quality of Life for individuals with Insulin Dependent Diabetes Mellitus (IDDM) can be severely impaired by acute and chronic complications of the disease.

Solid organ pancreatic transplantation restores endocrine pancreatic function. However, it is also burdened by high perioperative morbidity and mortality.

Clinical benefits and risks of this intervention have been extensively clarified, but our knowledge about quality of life gain, often mentioned among the assets of transplantation, is still limited.

This study aims to quantify the impact of all forms of Solid Organ Pancreas Transplantation on quality of life (QOL).

Detailed Description

Rationale of the study:

There are 3.5 million people in the United Kingdom diagnosed with diabetes. Their life expectancy is significantly reduced when compared to non-diabetic population. The long standing poor metabolic control causes a cluster of complications such as metabolic instability, cardiovascular disease, nephropathy, retinopathy and neuropathy which have a major impact on the clinical and social wellbeing of these individuals.

Solid organ pancreatic transplantation restores endocrine pancreatic function, but it is still burdened by significant perioperative morbidity and mortality.

There are other less invasive transplant options we can offer to this cohort of patients. The most common are Kidney Transplant Alone (KTA) from deceased or living donor in the diabetic and uremic patients and Islets Transplant (IT) for those with hypoglycemia unawareness and preserved renal function.

Although current literature suggests that the less invasive approaches may be less effective in the long term, potentially they could resolve the most compelling clinical needs at a lower surgical risk.

There is now a general consensus that the surgical risks of pancreatic solid organ transplantation must be weighed against clinical outcomes as well as QOL gain

Aims of the study:

This study aims to quantify QOL trajectory pre- and post- pancreas transplantation and identify correlations between QOL and clinical outcomes. The data collected will be utilized to understand which forms of solid organ pancreas transplantation are associated with greater/ lesser QOL gain and to compute a cost effectiveness analysis of this intervention.

Methods:

The core of the study will be a prospective quasi-experimental design focusing on QOL outcomes for patients on the pancreas transplant waiting-list at Oxford University Transplant Centre.

Patients active on the Oxford Transplant Centre Pancreas Transplant Waiting list will be invited to take part to this study.

Participants will be requested to complete one set of validated generic and disease specific (diabetes and kidney failure where applicable) QOL questionnaires pre-transplantation and at three time points post-transplantation: 6 weeks, 6 months and 1 year. The research team will collect clinical and hospital usage data at the same time points.

At the end of data collection, statistical analysis will aim to discern overall QOL changes in terms of Quality Adjusted Life Years (QALY), but also whether different cohorts of pancreas transplant recipients (SPK, PAK, and PTA) have different QOL outcomes and in which domains of QOL they differ.

A cohort of patients who receive a PT will be matched to a cohort of patients who remain on the PT waiting-list. Matching estimators, including Propensity Score and Coarsened Exact Matching, will be used to achieve covariate balance between the synthetic treated and control groups in order to estimate the causal effect of QoL changes post-transplantation.

Cumulative hospital costs of care by treatment group will be analysed using appropriate regression methods for non-normal, continuous outcomes. Continuous QOL outcomes will be analysed using generalised linear models.

Study Timeline

• Study Start: 2018-11-04
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Status Verified: 2021-07
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Willing and able to give informed consent for participation in the study
• Insulin Dependent Diabetic Patients
• Active on Pancreas Transplant Wait List

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Exclusion Criteria

• Not fluent in English

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simultaneous Pancreas Kidney Transplant Recipients	Solid Organ Pancreas Transplantation with or without Kidney Transplantation	Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Simultaneous Pancreas Kidney Transplant (SPK)
Pancreas Transplant Alone Recipients	Solid Organ Pancreas Transplantation with or without Kidney Transplantation	Patient affected by Insulin Dependent Diabetes Mellitus with hypoglycemia unawareness undergoing Pancreas Transplant Alone (PTA)
Pancreas after kidney Transplant Recipients	Solid Organ Pancreas Transplantation with or without Kidney Transplantation	Patient affected by Insulin Dependent Diabetes Mellitus and renal failure undergoing Pancreas after kidney Transplant (PAK)

Primary Outcome Measures

Name	Time	Method
Quantification of Quality of Life	pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation	Completion of Short Form 12 v.2 questionnaire (SF-12 v.2®) includes 8 domains and 12 items that form two Components: Physical Health Component (PCS) and Mental Health Component (MCS) A computer-based scoring algorithm is used to calculate scores: Physical Component Summary (PCS) and Mental (MCS) Component Summary scales are generated using norm-based methods. Scores are transformed to have a mean value of 50, standard deviation (SD) 10, where scores above or below 50 are above or below average physical or mental well-being, respectively.

Secondary Outcome Measures

Name	Time	Method
Estimate cost-effectiveness of pancreas transplantation	pre- transplant, 1 year	calculation of Quality Adjusted Life Years (QALYs) As per NICE recommendation, utility scores derived by EQ5D5L will be used to calculate Quality Adjusted Life Years before transplantation and at one year from transplant to calculate QALY gain after pancreas transplantation
Correlation between clinical status and quality of life pre-transplantation	pre-transplantation, 6/52 post transplantation, 6/12 post transplantation, 1 year post transplantation	Identification of which clinical phenotypes correspond to higher quality of life scores collection of clinical data at the same time points as quality of life questionnaires to establish correlation/causal effect between clinical and qol data

Trial Locations

Locations (1)

Oxford University Hospital NHS Foundation Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom